Asthma AttackNCT07116460
Cost Effective Air Filtration Intervention in Low-Income Housing to Reduce Asthma Morbidity
A study testing Austin Air Cleaner in people with Asthma Attack and Lung Function, run by Columbia University at 1 site in United States.
Trial summary
This project will investigate the effectiveness of HEPA air cleaners in reducing indoor air pollution and improving asthma morbidity in children living in East Harlem, New York City (NYC). The study will be conducted over a 2-year period. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma Attack, Lung Function, Airway Inflammation
- What is being tested?
- Austin Air Cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 7-18 years
- Asthma symptoms in the past 4 weeks
- Resident in lower-income housing in NYC Northern Manhattan and South Bronx
Who cannot join
- Inability to successfully perform spirometry maneuver or FeNO test
- Family planning to move in the next year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Cost Effective Air Filtration Intervention and Particulate Matter Monitoring in Low-Income Housing to Reduce Asthma Morbidity
This project will investigate the effectiveness of HEPA air cleaners in reducing indoor air pollution and improving asthma morbidity in children living in East Harlem, New York City (NYC). The study will be conducted over a 2-year period.
Columbia University and Little Sisters of the Assumption Family Health Service (LSAFHS) will conduct an intervention study to evaluate the efficacy of using a cost-effective high-capacity high efficiency particulate air (HEPA) filter air cleaner to reduce airborne particulate matter (PM) in the homes of children with asthma and to reduce their asthma morbidity. The study will take place in East Harlem, a low-income neighborhood with high asthma prevalence. It will build on findings from prior Housing and Urban Development Lead and Healthy Homes Technical Studies (HUD LHHTS)-funded research, the experience of LSAFHS installing air cleaners in the homes of asthmatic children, and recent findings demonstrating the effectiveness of home air cleaners in reducing asthma morbidity. The investigators hypothesize that the cost-effective single air cleaner will substantially reduce PM exposure in the homes of asthmatic children and reduce airway inflammation and asthma morbidity. This study will use cutting-edge air sampling technology to continuously quantify and characterize indoor air pollutants in the home for one year, verify and incentivize compliance, and conduct repeated exhaled nitric oxide and pulmonary function tests before and throughout the year after the intervention. This cost-effective intervention can be easily and quickly implemented in homes in low-income, urban communities and easily transferred between homes if families move.
Read the detailed description
The investigators propose an intervention study to evaluate if using a cost-effective high-capacity air filter will reduce air pollutants in the homes of asthmatic children and reduce their asthma symptoms. The study will take place in New York City, including East Harlem, a low-income, primarily Latino neighborhood with high asthma prevalence. The investigators hypothesize that a cost-effective single air cleaner placed in the homes of asthmatic children will substantially reduce air pollutants exposure and reduce airway inflammation and asthma symptoms. During the intervention, the study team will continuously monitor indoor air pollution by measuring particulate matter (tiny particles suspended in the air) for one year, verify and incentivize compliance, and conduct two types of breathing tests on the asthmatic child throughout the intervention: 1. One test measures exhaled nitric oxide (a gas collected by blowing air in a portable device, the levels of this gas are higher when there is inflammation in the airways), and 2. The second breathing test is a pulmonary function test (to measure lung capacity and diameter of the airways). The study team will also collect asthma symptom information through questionnaires. If successful, this study will provide evidence for a cost-effective intervention implemented without structural housing changes that can be easily and quickly implemented in homes in low-income urban communities. This study design will utilize a set of air monitors that will allow for high resolution quantification and characterization of particulate matter in the home before the intervention and one-year after placement of the air filter, which will allow researchers to better understand the impact of the filter on home air quality throughout the year. The study team will test the hypothesis that the single filter will substantially reduce particulate matter in the homes of asthmatic children and reduce airway inflammation and asthma morbidity in the child.
- Conditions
- Asthma Attack, Lung Function, Airway Inflammation
- Being tested
- Austin Air Cleaner
- Keywords
- asthma, air cleaner, particulate matter, pm2.5, lung function, airway inflammation, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Austin Air CleanerDevice
The Austin Air Purifier consists of 4 stages, a large particle pre-filter, medium pre-filter, a medical grade HEPA filter and a high efficiency gas arrestance carbon cloth to reduce air pollution in homes.
| Study group | Role | What they receive |
|---|---|---|
| Air Cleaner Intervention | Experimental | Participants in this single arm of the study will be enrolled for a one-year trial of a HEPA air cleaner. Subjects will serve as their own controls. Receives: Device: Austin Air Cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Exhaled Nitric Oxide (FeNO)
A portable fractional exhaled nitric oxide (FeNO) monitor will used to measure exhaled NO, a biomarker of airway inflammation. FeNO will be measured at four timepoints with respect to the time the air cleaner is turned on.
Measured: 1 week before, immediately before, two weeks after, and one year after the air cleaner is turned on.
Forced Expiratory Volume in 1 Second/ Forced Vital Capacity (FEV1/FVC) Ratio
Easy to use, pocket-size spirometers (MIR) will be delivered to the homes along with the initial delivery of equipment. Subjects will be thoroughly trained on how to perform a pulmonary function test (PFT). These spirometers connect via Bluetooth to an application previously installed on the subject's cell phone. PFT data will be downloaded onto Columbia University computers from the app and the results will be scored and validated by trained personnel under the supervision of a spirometry expert.
FEV1/FVC measures the proportion of vital capacity expired in the first second of forced expiration to the full forced vital capacity (how much air can be exhaled). FEV1/FVC will be measured at 15 timepoints with respect to the time the air cleaner is turned on.
Measured: 1 week before, immediately before, two weeks after, then once a month (up to 1 year) after the air cleaner is turned on.
Number of Attacks of Wheezing
The number of attacks of wheezing in the past 4 weeks will be reported.
Measured: Once per month for up to 12 months after the air cleaner is turned on
Number of Emergency Department (ED) Visits
Number of ED visits in the past year.
Measured: 12 months after the air cleaner is turned on
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Jan 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AttackStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be enrolled for a one-year trial of a HEPA air cleaner. All subjects will receive the air cleaner. Subjects will serve as their own controls. Given the existing evidence that air cleaners can reduce asthma morbidity, a sham or control group does not seem to be necessary nor ethically sound for this intervention.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Little Sisters of the Assumption Family Health Service
- Responsible party
- Principal investigator, Matthew S. Perzanowski, Columbia University
- Investigators
- Matthew S Perzanowski, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116460
- Sponsor's protocol ID
- AAAV8505
- Other IDs
- NYHHU009624
- Status last verified
- May 2026
- First submitted
- 7 Aug 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared when the study results are published.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effective Air Filtration Intervention and Particulate Matter Monitoring in Low-Income Housing to Reduce Asthma Morbidity
- ClinicalTrials.gov ID
- NCT07116460
- Acronym / sponsor ID
- AAAV8505
- Conditions
- Asthma Attack, Lung Function, Airway Inflammation
- Keywords
- asthma, air cleaner, particulate matter, pm2.5, lung function, airway inflammation, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Little Sisters of the Assumption Family Health Service
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will investigate the effectiveness of HEPA air cleaners in reducing indoor air pollution and improving asthma morbidity in children living in East Harlem, New York City (NYC). The study will be conducted over a 2-year period.
Columbia University and Little Sisters of the Assumption Family Health Service (LSAFHS) will conduct an intervention study to evaluate the efficacy of using a cost-effective high-capacity high efficiency particulate air (HEPA) filter air cleaner to reduce airborne particulate matter (PM) in the homes of children with asthma and to reduce their asthma morbidity. The study will take place in East Harlem, a low-income neighborhood with high asthma prevalence. It will build on findings from prior Housing and Urban Development Lead and Healthy Homes Technical Studies (HUD LHHTS)-funded research, the experience of LSAFHS installing air cleaners in the homes of asthmatic children, and recent findings demonstrating the effectiveness of home air cleaners in reducing asthma morbidity. The investigators hypothesize that the cost-effective single air cleaner will substantially reduce PM exposure in the homes of asthmatic children and reduce airway inflammation and asthma morbidity. This study will use cutting-edge air sampling technology to continuously quantify and characterize indoor air pollutants in the home for one year, verify and incentivize compliance, and conduct repeated exhaled nitric oxide and pulmonary function tests before and throughout the year after the intervention. This cost-effective intervention can be easily and quickly implemented in homes in low-income, urban communities and easily transferred between homes if families move.
Detailed description
The investigators propose an intervention study to evaluate if using a cost-effective high-capacity air filter will reduce air pollutants in the homes of asthmatic children and reduce their asthma symptoms. The study will take place in New York City, including East Harlem, a low-income, primarily Latino neighborhood with high asthma prevalence. The investigators hypothesize that a cost-effective single air cleaner placed in the homes of asthmatic children will substantially reduce air pollutants exposure and reduce airway inflammation and asthma symptoms. During the intervention, the study team will continuously monitor indoor air pollution by measuring particulate matter (tiny particles suspended in the air) for one year, verify and incentivize compliance, and conduct two types of breathing tests on the asthmatic child throughout the intervention: 1. One test measures exhaled nitric oxide (a gas collected by blowing air in a portable device, the levels of this gas are higher when there is inflammation in the airways), and 2. The second breathing test is a pulmonary function test (to measure lung capacity and diameter of the airways). The study team will also collect asthma symptom information through questionnaires. If successful, this study will provide evidence for a cost-effective intervention implemented without structural housing changes that can be easily and quickly implemented in homes in low-income urban communities. This study design will utilize a set of air monitors that will allow for high resolution quantification and characterization of particulate matter in the home before the intervention and one-year after placement of the air filter, which will allow researchers to better understand the impact of the filter on home air quality throughout the year. The study team will test the hypothesis that the single filter will substantially reduce particulate matter in the homes of asthmatic children and reduce airway inflammation and asthma morbidity in the child.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be enrolled for a one-year trial of a HEPA air cleaner. All subjects will receive the air cleaner. Subjects will serve as their own controls. Given the existing evidence that air cleaners can reduce asthma morbidity, a sham or control group does not seem to be necessary nor ethically sound for this intervention.
| Arm | Type | Receives |
|---|---|---|
| Air Cleaner Intervention | Experimental | Device: Austin Air CleanerParticipants in this single arm of the study will be enrolled for a one-year trial of a HEPA air cleaner. Subjects will serve as their own controls. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 7-18 years
- Asthma symptoms in the past 4 weeks
- Resident in lower-income housing in NYC Northern Manhattan and South Bronx
Key exclusion criteria (2 listed)
- Inability to successfully perform spirometry maneuver or FeNO test
- Family planning to move in the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Austin Air CleanerThe Austin Air Purifier consists of 4 stages, a large particle pre-filter, medium pre-filter, a medical grade HEPA filter and a high efficiency gas arrestance carbon cloth to reduce air pollution in homes. | Device | Air Cleaner Intervention |
Primary outcome
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: 1 week before, immediately before, two weeks after, and one year after the air cleaner is turned on.
A portable fractional exhaled nitric oxide (FeNO) monitor will used to measure exhaled NO, a biomarker of airway inflammation. FeNO will be measured at four timepoints with respect to the time the air cleaner is turned on.
Forced Expiratory Volume in 1 Second/ Forced Vital Capacity (FEV1/FVC) Ratio
Time frame: 1 week before, immediately before, two weeks after, then once a month (up to 1 year) after the air cleaner is turned on.
Easy to use, pocket-size spirometers (MIR) will be delivered to the homes along with the initial delivery of equipment. Subjects will be thoroughly trained on how to perform a pulmonary function test (PFT). These spirometers connect via Bluetooth to an application previously installed on the subject's cell phone. PFT data will be downloaded onto Columbia University computers from the app and the results will be scored and validated by trained personnel under the supervision of a spirometry expert. FEV1/FVC measures the proportion of vital capacity expired in the first second of forced expiration to the full forced vital capacity (how much air can be exhaled). FEV1/FVC will be measured at 15 timepoints with respect to the time the air cleaner is turned on.
Number of Attacks of Wheezing
Time frame: Once per month for up to 12 months after the air cleaner is turned on
The number of attacks of wheezing in the past 4 weeks will be reported.
Number of Emergency Department (ED) Visits
Time frame: 12 months after the air cleaner is turned on
Number of ED visits in the past year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared when the study results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew S Perzanowski, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Austin Air Cleaner in people with Asthma Attack and Lung Function, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew S Perzanowski, PhD ((212) 305-3465, mp2217@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Exhaled Nitric Oxide (FeNO) (time frame: 1 week before, immediately before, two weeks after, and one year after the air cleaner is turned on.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.